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Completed

NCT Number: NCT04979403

Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?

Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). This is probably due to the multiple factors associated with CLBP which are biophysical, psychological and social. Thus, each patient presents with a unique profile of factors contributing to their pain and could benefit from an approach tailored to their profile. In other words, it is crucial to identify the right treatment, for the right person, at the right moment. For example, the presence of important psychological factors such as anxiety and depression are risk factors for low back pain to develop and persist over time. The main aim of this project is to determine the feasibility to perform a large clinical trial comparing the efficacy of a two physiotherapy's approaches to treat CLBP (i.e., a psychologically-informed physiotherapy intervention compared to usual physiotherapy) in patients with CLBP presenting a high level of psychological factors.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)

Québec, Quebec, G1M 2S8, Canada

About this study

Low back pain is presently the first cause of disability worldwide. The most recommended interventions by clinical guidelines are exercises and cognitive behavioral therapy although the effect is modest. However, no approach is superior when given to a heterogeneous group of subjects with chronic low back pain (CLBP). This is probably due to the multiple factors associated with CLBP which are biophysical, psychological and social. Thus, each patient presents with a unique profile of factors contributing to their pain and could benefit from an approach tailored to their profile. In other words, it is crucial to identify the right treatment, for the right person, at the right moment. For example, the presence of important psychological factors such as anxiety and depression are risk factors for low back pain to develop and persist over time. Empowerment of physiotherapists and patients on the optimal management of psychosocial factors, in addition of the usual care delivered in physiotherapy, may be a potent strategy to improve the treatment effect especially with patients presenting a complex clinical profile. This empowerment may be done through psychologically-informed physiotherapy, an approach incorporating strategies from cognitive behavioral therapy into the physiotherapy usual practice. However, the feasibility to perform a clinical trial including psychologically-informed physiotherapy in the context of the Quebec's healthcare system remains to be verified.

The main aim of this project is to determine the feasibility to perform a pilot randomised controlled trial testing the efficacy of a psychologically-informed physiotherapy intervention in CLBP patients with a high level of psychosocial factors compared to usual physiotherapy. Specific aims are related to feasibility (1) and sample size estimation (2):

  • To test (a) strategies to recruit participants with high level of psychosocial factors and physiotherapists (PT) (recruitment rate and retention), (b) the physiotherapists and participants adherence to intervention, (c) the risk of contamination between treatment sites and (d) specific challenges;
  • To gather data to estimate the required sample size for a future full-scale randomized clinical trial using physical functioning as main outcome, and pain intensity, quality of life, fear of movement, catastrophizing, self-efficacy, pain pressure threshold, exercise-induced hypoalgesia and temporal summation as additional outcomes.

The hypothesis is that this project will be feasible in terms of recruitment for both patients (~30) and PT (6-8), will show good patients and physiotherapists' adherence to intervention and low contamination between treatment sites. An improvement for all pain-related outcomes in both groups, but more in the psychologically-informed physiotherapy group, is also expected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-specific chronic low back pain (> 3 months)
  • High level of psychosocial factors (a high level using the Start Back Screening Tool, i.e., cut-off of at least 4 points (total score) and at least 4 points (sub-score with questions 5 to 9)).

Exclusion criteria

  • Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, infection)
  • Neuropathic conditions (e.g., radiculopathy).
  • Currently in litigation with paying agencies

Treatment and study plan

Physiotherapy

Other

Participants from each group will receive 8 intervention sessions (45 min) over 11 weeks by a physiotherapist. For both groups, each intervention will be tailored to the patient's profile and the choice of interventions and parameters will be at the judgment of the physiotherapist.

Primary outcomes

  1. Recruitment rate of participants

    Time frame: Baseline

    The number of participants contacted divided by the number of participants recruited.

  2. Physiotherapists adherence to intervention

    Time frame: Week 6

    Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).

  3. Risk of contamination between treatment sites

    Time frame: Week 6

    The list of interventions used by physiotherapists at each site will be compared to evaluate the risk of contamination between treatment sites.

  4. Specific challenges

    Time frame: Through data collection completion, an average of 1 year

    Using semi-structured interview with the physio.

  5. Retention of participants

    Time frame: Baseline, when a participant drop out

    The number of participants who completed the study divided by the number of participants that were recruited.

  6. Participants adherence to intervention

    Time frame: Week 6

    Participants will measure their adherence to intervention on a Numeric Rating Scale from 0 (not adherent at all) to 10 (completely adherent).

Secondary outcomes

  1. Physical functioning (ODI)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability).

  2. Pain intensity (NRS)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Numeric Rating Scale (NRS) is an 11-point scale used to score the intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).

  3. Quality of life (SF-12)

    Time frame: Baseline, Weeks 6, 12 and 24

    The 12-Item Short Form Survey is a self-completed questionnaire counting 12 questions on eight mental and physical health domains. The score is calculated by a specific calculator that compares the score to the general population.

  4. Fear of movement (TSK-11)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Tampa Scale of Kinesiophobia is a self-completed questionnaire used to assess fear of movement using 11 questions on a 4-point scale ranging from 1 (strongly disagree, low level of kinesiophobia) to 4 (strongly agree, high level of kinesiophobia).

  5. Catastrophizing thoughts (PCS)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Pain Catastrophizing Scale (PCS) is a self-completed questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point scale ranging from 0 (not at all, low level of catastrophizing thoughts) to 5 (all the time, high level of catastrophizing thoughts).

  6. Self-efficacy (CPSES)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Chronic Pain Self-Efficacy Scale (CPSES) (short form) is a self-completed questionnaire of 6 questions measuring self-efficacy on a 10-point scale from 0 (not at all confident, low self-efficacy) to 10 (completely confident, high self-efficacy).

  7. Participant's expectations

    Time frame: Baseline, Weeks 6, 12 and 24

    Participant's expectations regarding treatment will be measured with a self-completed questionnaire of three 7-level Likert questions on pain, physical functioning and participation ranging from 0 (way better) to 6 (way worst).

  8. Central Sensitization (CSI)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Central Sensitization Index (CSI) is a self-completed questionnaire of 9 questions measuring central sensitization on a 5-point scale from 0 (never, low level of central sensitization) to 5 (always, high level of central sensitization).

  9. Global rating of change (GRC)

    Time frame: Baseline, Weeks 6, 12 and 24

    The Global rating of change (GRC) is a 11-point scale ranging from -5 (a great deal worst) to 5 (a great deal better) to measure the perceived change oh health status after the intervention.

  10. Pain pressure threshold

    Time frame: Baseline, Week 6

    Pain pressure thresholds will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a digital algometer before and after an exercise of wrist flexion (maintaining 25% of the maximal voluntary contraction activity during 4 minutes) to test the exercise-induced hypoalgesia paradigm.

  11. Temporal summation

    Time frame: Baseline, Week 6

    Temporal summations will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a pinprick before the exercise of wrist flexion.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
  • Fonds de la Recherche en Santé du Québec
  • Ordre professionnel de la physiothérapie du Québec

Registry information

Official study title

Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients With Chronic Low Back Pain With a High Level of Psychosocial Factors: a Feasibility and Pilot Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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